State-level policies and receipt of CDC-informed opioid thresholds among commercially insured new chronic opioid users.

OBJECTIVES: To evaluate the association of state-level policies on receipt of opioid regimens informed by Centers for Disease Control and Prevention (CDC) morphine milligram equivalent (MME)/day recommendations. DESIGN: A retrospective cohort study of new chronic opioid users (NCOUs). SETTING: Commercially insured plans across the United States using IQVIA PharMetrics® Plus for Academics database with new chronic use between January 2014 and March 2015. PARTICIPANTS: NCOUs with ≥60-day coverage of opioids within a 90-day period with ≥30-day opioid-free period prior to the date of the first qualifying opioid prescription. INTERVENTIONS: State-level policies including Prescription Drug Monitoring Program (PDMP) robustness and cannabis policies involving the presence of medical dispensaries and state-wide decriminalization. MAIN OUTCOME MEASURES: NCOUs were placed in three-tiered risk-based average MME/day thresholds: low (>0 to <50), medium (≥50 to <90), and high (≥90). Multinomial logistic regression was used to estimate the association of state-level policies with the thresholds while adjusting for relevant patient-specific factors. RESULTS: NCOUs in states with medium or high PDMP robustness had lower odds of receiving medium (adjusted odds ratio [AOR] 0.74; 95 percent confidence interval [CI]: 0.62-0.69) and high (AOR 0.74; 95 percent CI: 0.59-0.92) thresholds. With respect to cannabis policies, NCOUs in states with medical cannabis dispensaries had lower odds of receiving high (AOR 0.75; 95 percent CI: 0.60-0.93) thresholds, while cannabis decriminalization had higher odds of receiving high (AOR 1.24; 95 percent CI: 1.04-1.49) thresholds. CONCLUSION: States with highly robust PDMPs and medical cannabis dispensaries had lower odds of receiving higher opioid thresholds, while cannabis decriminalization correlated with higher odds of receiving high opioid thresholds.

Short-term healthcare resource utilization associated with receipt of CDC-informed opioid thresholds among commercially insured new chronic opioid users.

OBJECTIVE: To evaluate the impact of recent changes to the Centers for Disease Control and Prevention (CDC) morphine milligram equivalent (MME)/day threshold recommendations on healthcare utilization. DESIGN: A retrospective cohort study of new chronic opioid users (NCOUs). SETTING: Commercially insured plans across the United States using IQVIA PharMetrics® Plus for Academics database with new use between January 2014 and March 2015. PATIENTS: NCOUs with ≥60-day coverage of opioids within a 90-day period with ≥30-day opioid-free period prior to the date of the first qualifying opioid -prescription. INTERVENTIONS: NCOU categorized by the CDC three-tiered risk-based average MME/day thresholds: low (>0 to <50), medium (≥50 to <90), and high (≥90). MAIN OUTCOME MEASURES: Multivariable logistic regression was used to calculate adjusted odds of incurring an acute care encounter (ACE) (all-cause and opioid-related) between the thresholds (adjusted odds, 95 percent confidence interval). RESULTS: In adjusted analyses, when compared to low threshold, there was no difference in the odds of all-cause ACE across the medium (1.01, 0.94-1.28) and high (1.01, 0.84-1.22) thresholds. When compared to low threshold, a statistically insignificant increase was observed when evaluating opioid-related ACE among medium (1.86, 0.86-4.02) and high (1.51, 0.65-3.52) thresholds. CONCLUSIONS: There was no difference in odds of an all-cause or opioid-related ACE associated with the thresholds. Early-intervention programs and policies exploring reduction of MME/day among NCOUs may not result in short-term reduction in all-cause or opioid-related ACEs. Further assessment of potential long-term reduction in ACEs among this cohort may be insightful.

Evaluating the sensitivity of EQ-5D-5L in patients with brain metastases: a secondary analysis of NRG CC001.

BACKGROUND: EuroQoL EQ-5D is a commonly used measure of health-related quality of life (HRQOL) in clinical trials given the use of its index score as a measure of health utilities. It is unclear whether EQ-5D is sensitive to changes in neurocognitive function and progression that occur following brain radiation. This study sought to evaluate the sensitivity of EQ-5D-5L in reflecting these changes. PATIENTS AND METHODS: A secondary analysis of NRG Oncology CC001 was performed. Mean EQ-5D-5L index and visual analog scale (VAS) score changes from baseline between groups of patients stratified by neurocognitive function and intracranial progression status were assessed. MD Anderson Symptom Inventory for brain tumor (MDASI-BT) symptom and interference items were also analyzed between groups. RESULTS: EQ-5D-5L index and VAS score changes between patients who had cognitive failure and those that had preserved cognition showed no significant differences at any time point. In contrast, VAS changes at 4 (1.61 vs -5.13, P = .05) and 6 months (8.17 vs -0.14, P = .04) were significantly improved in the patients who survived without intracranial progression.MDASI-BT cognitive factor scores were significantly improved in the cohort of patients with preserved neurocognitive function at 2 (1.68 vs 2.08, P = .05) and 4 months (1.35 vs 1.83, P = .04). MDASI-BT symptom interference was significantly associated with intracranial progression at 4 months, but not with neurocognitive status. CONCLUSION: EQ-5D-5L index and VAS scores were not sensitive to neurocognitive changes that patients experienced, but VAS scores were sensitive to progression. This study challenges the routine use of EQ-5D as a QoL metric in brain metastases clinical trials that are focused on preventing neurocognitive dysfunction. TRIAL REGISTRATION: NCT# 02360215.

Studying the impact of COVID-19 mitigation policies on childhood obesity, health behaviors, and disparities in an observational cohort: Protocol for the COVID-19 Family Study.

BACKGROUND: COVID-19 pandemic control policies, including school closures, suspended extra-curricular activities, and social distancing, were introduced to prevent viral transmission, and disrupted children's daily routines, health behaviors, and wellness. This observational cohort study among 697 families with children or adolescents, based on the Family Stress Model, aims to: 1) evaluate pre- to during-pandemic changes in child health behaviors (diet, physical activity, sleep) and weight gain, 2) identify mechanisms explaining the changes, and 3) determine projected healthcare costs on weight gain and obesity. Each aim includes an examination by racial and ethnic, socioeconomic, and geographic disparities. METHODS: The study employs a mixed methods design, recruiting children and their caregivers from two obesity prevention trials halted in 2020. Enrolled participants complete annual surveys to assess child health behaviors, family resources, routines, and demographics, and home environment in 2020-2022. Height and weight are measured annually in 2021-2022. Annual semi-structured interviews are conducted within a subsample to understand mechanisms of observed changes. Multilevel mixed models and mediation analyses are used to examine changes in child health behaviors and weight gain and mechanisms underlying the changes. Qualitative data are analyzed within and across time points and integrated with quantitative findings to further explain mechanisms. Markov models are used to determine healthcare costs for unhealthy child behaviors and weight gain. CONCLUSION: Findings from this study will aid in understanding pandemic-related changes in child health behaviors and weight status and will provide insights for the implementation of future programs and policies to improve child and family wellness.

The State of Use and Utility of Negative Controls in Pharmacoepidemiologic Studies.

Uses of real-world data in drug safety and effectiveness studies are often challenged by various sources of bias. We undertook a systematic search of the published literature through September 2020 to evaluate the state of use and utility of negative controls to address bias in pharmacoepidemiologic studies. Two reviewers independently evaluated study eligibility and abstracted data. Our search identified 184 eligible studies for inclusion. Cohort studies (115, 63%) and administrative data (114, 62%) were, respectively, the most common study design and data type used. Most studies used negative control outcomes (91, 50%), and for most studies the target source of bias was unmeasured confounding (93, 51%). We identified 4 utility domains of negative controls: 1) bias detection (149, 81%), 2) bias correction (16, 9%), 3) P-value calibration (8, 4%), and 4) performance assessment of different methods used in drug safety studies (31, 17%). The most popular methodologies used were the 95% confidence interval and P-value calibration. In addition, we identified 2 reference sets with structured steps to check the causality assumption of the negative control. While negative controls are powerful tools in bias detection, we found many studies lacked checking the underlying assumptions. This article is part of a Special Collection on Pharmacoepidemiology.

Direct Medical Costs of COPD in the USA: An Analysis of the Medical Expenditure Panel Survey 2017-2018.

AIM: In this study, we aimed to provide a nationally representative estimate of the economic burden of chronic obstructive pulmonary disease (COPD) by examining direct medical costs among individuals aged 45 years and older in the USA. METHODS: Medical Expenditure Panel Survey (2017-2018) data were used to estimate the direct medical costs associated with COPD. All-cause (unadjusted) cost and COPD-specific (adjusted) cost were determined for the various service categories using a regression-based approach among patients with COPD. We developed a weighted two-part model and adjusted for various demographic, socioeconomic, and clinical characteristics. RESULTS: The study sample consisted of 23,590 patients, of which 1073 had COPD. Patients with COPD had a mean age of 67.4 years (standard error (SE): 0.41), and the total all-cause mean medical cost per patient per year (PPPY) was 2018 US $19,449 (SE: US $865), of which US $6145 (SE: US $295) was for prescription drugs. Using the regression approach, the mean total COPD-specific cost was US $4322 (SE: US $577) PPPY, with prescription drugs contributing US $1887 (SE: 216) PPPY. These results represented an annual total COPD-specific cost of US $24.0 billion, with prescription drugs contributing US $10.5 billion. The mean annual out-of-pocket spending accounted for 7.5% (mean: US $325) of the total COPD-specific cost; for COPD-specific prescription drug cost, 11.3% (mean: US $212) was out-of-pocket cost. CONCLUSION: COPD poses a significant economic burden on healthcare payers and patients 45 years of age and older in the USA. While prescription drugs accounted for almost half of the total cost, more than 10% of the prescription drug cost was out-of-pocket.

Impact of different interventions on preventing suicide and suicide attempt among children and adolescents in the United States: a microsimulation model study.

Introduction: Despite considerable investment in suicide prevention since 2001, there is limited evidence for the effect of suicide prevention interventions among children and adolescents. This study aimed to estimate the potential population impact of different interventions in preventing suicide-related behaviors in children and adolescents. Methods: A microsimulation model study used data from national surveys and clinical trials to emulate the dynamic processes of developing depression and care-seeking behaviors among a US sample of children and adolescents. The simulation model examined the effect of four hypothetical suicide prevention interventions on preventing suicide and suicide attempt in children and adolescents as follows: (1) reduce untreated depression by 20, 50, and 80% through depression screening; (2) increase the proportion of acute-phase treatment completion to 90% (i.e., reduce treatment attrition); (3) suicide screening and treatment among the depressed individuals; and (4) suicide screening and treatment to 20, 50, and 80% of individuals in medical care settings. The model without any intervention simulated was the baseline. We estimated the difference in the suicide rate and risk of suicide attempts in children and adolescents between baseline and different interventions. Results: No significant reduction in the suicide rate was observed for any of the interventions. A significant decrease in the risk of suicide attempt was observed for reducing untreated depression by 80%, and for suicide screening to individuals in medical settings as follows: 20% screened: -0.68% (95% credible interval (CI): -1.05%, -0.56%), 50% screened: -1.47% (95% CI: -2.00%, -1.34%), and 80% screened: -2.14% (95% CI: -2.48%, -2.08%). Combined with 90% completion of acute-phase treatment, the risk of suicide attempt changed by -0.33% (95% CI: -0.92%, 0.04%), -0.56% (95% CI: -1.06%, -0.17%), and -0.78% (95% CI: -1.29%, -0.40%) for reducing untreated depression by 20, 50, and 80%, respectively. Combined with suicide screening and treatment among the depressed, the risk of suicide attempt changed by -0.27% (95% CI: -0.dd%, -0.16%), -0.66% (95% CI: -0.90%, -0.46%), and -0.90% (95% CI: -1.10%, -0.69%) for reducing untreated depression by 20, 50, and 80%, respectively. Conclusion: Reducing undertreatment (the untreated and dropout) of depression and suicide screening and treatment in medical care settings may be effective in preventing suicide-related behaviors in children and adolescents.

Impacts of Covid-19 School Closures on School Food Service Revenue: Analysis of Public Local Education Agencies in Maryland.

BACKGROUND: The public health policies and school closures in response to the Covid-19 pandemic have created disruptions in school meal programs. Research is needed to understand the changes in school food service revenue before and during the initial Covid-19-related school shutdowns. METHODS: A longitudinal cohort study examining federal and state reimbursements as well as sales revenues for all public local education agencies (LEAs) in Maryland from school years (SY) 2018-2019 and 2019-2020 was conducted. Monthly changes in federal and state reimbursements for Child Nutrition Programs, including the National School Lunch Program (NSLP), School Breakfast Program (SBP), Summer Food Service Program (SFSP), and Child and Adult Care Food Program (CACFP) were examined. RESULTS: In the SY 2018-2019, the total revenues from federal and state reimbursements for SBP, NSLP, SFSP, and at-risk CACFP were $272.9 million; in comparison, for the SY 2019-2020, the total revenues were $241.8 million (11.4% reduction from SY 2018-2019). On average, the school shutdown (during March to June 2020) was associated with a $450,385 (p-value < .01) reduction in federal and state reimbursements per LEA-month (41% reduction). CONCLUSIONS: The school shutdown during the Covid-19 pandemic was associated with a statistically significant reduction in school food service revenues across Maryland's public LEAs.

Impact of Undertreatment of Depression on Suicide Risk Among Children and Adolescents With Major Depressive Disorder: A Microsimulation Study.

Undertreatment of depression is common among children and adolescents, but evidence of the impact of undertreatment of depression on risk of suicide is limited due to the low base rate of suicide in the population and lack of sufficient data sources. We developed a microsimulation model that uses evidence from multiple sources to study the impact of different durations of antidepressant treatment on suicide risk in a synthesized sample that is nationally representative of children and adolescents with major depressive disorder. Compared with receiving no treatment, suicide rate and risk of suicide attempt both decreased with increasing duration of antidepressant treatment (for 12 weeks, suicide rate ratios = 0.78 (95% credible interval (CrI): 0.58, 1.15), 36 weeks, 0.65 (95% CrI: 0.44, 0.90), and 52 weeks, 0.63 (95% CrI: 0.45, 0.72); for suicide attempt: 12 weeks, suicide risk ratios = 0.68 (95% CrI: 0.62, 0.69), 36 weeks, 0.56 (95% CrI: 0.52, 0.57), and 52 weeks, 0.55 (95% CrI: 0.51, 0.56). The suicide rate and risk of suicide attempt were lower in children than in adolescents. Males had a lower risk of suicide attempt but higher suicide rate than females. The findings from the microsimulation model show that completion of 12-36 weeks of antidepressant treatment may reduce suicide attempt and suicide among children and adolescents with major depressive disorder.

Willingness-to-pay tuition and risk-taking proclivities among public health students.

Objective: To quantify students' risk tolerance for in-person classes and willingness-to-pay for online-only instruction during the COVID-19 pandemic. Participants: 46 Columbia University public health graduate students. Methods: We developed a survey tool with a "standard gamble" exercise administered online by an interactive chat bot with full anonymity by students. Students were asked to trade between the risk of infection with COVID-19 and: (1) attending classes in-person, and (2) attending community parties. We also assessed willingness-to-pay for online-only tuition. Results: Students accepted a 23% (standard error [SE]: 4%) risk of infection to attend classes in-person and 15% of them expressed willingness to attend community parties even if the COVID-19 prevalence were high. Students were willing-to-pay only 48% (SE: 3%) of the regular, in-person tuition fees for online instruction. Conclusions: Public health students with a strong knowledge of COVID-19 transmission were willing to accept a significant risk of infection for in-person instruction.Trial registration:NA.

Modeling the Health and Economic Burden of Chronic Obstructive Pulmonary Disease in China From 2020 to 2039: A Simulation Study.

OBJECTIVES: Despite a growing prevalence of respiratory diseases in recent decades in China, limited evidence is available on the health and economic burden of chronic obstructive pulmonary disease (COPD). We estimated the 20-year health and economic burden of COPD in China from 2020 to 2039. METHODS: We created a probabilistic dynamic open-cohort Markov model of COPD for the Chinese population aged ≥40 years. Projections of population growth and urbanization rates were obtained from the United Nations Population Division. Other parameter inputs including smoking prevalence, COPD prevalence and severity distributions, disease-related costs, and utility weights were obtained from the most recent published literature. We modeled number of COPD patients, excess mortality due to COPD, exacerbations, COPD-attributable losses of quality-adjusted life-years, and direct and indirect COPD costs over the 20 years. RESULTS: The number of COPD patients was projected to increase from 88.3 million in 2020 to 103.3 million in 2039. The projected total losses of quality-adjusted life-years and the excess mortality due to COPD were, respectively, estimated to be 253.6 million and 3.9 million over the 20 years. The projected 20-year total discounted direct and indirect costs of COPD were, respectively, $3.1 trillion and $360.5 billion. The projected health and economic burden was higher in males and urban areas. CONCLUSIONS: COPD is projected to inflict a substantial burden to the society and the health care system in China. Effective strategies for prevention and early management of COPD are needed to mitigate the forthcoming disease burden.

The cost-effectiveness of standalone HEPA filtration units for the prevention of airborne SARS CoV-2 transmission.

OBJECTIVE: Airborne infection from aerosolized SARS-CoV-2 poses an economic challenge for businesses without existing heating, ventilation, and air conditioning (HVAC) systems. The Environmental Protection Agency notes that standalone units may be used in areas without existing HVAC systems, but the cost and effectiveness of standalone units has not been evaluated. STUDY DESIGN: Cost-effectiveness analysis with Monte Carlo simulation and aerosol transmission modeling. METHODS: We built a probabilistic decision-analytic model in a Monte Carlo simulation that examines aerosol transmission of SARS-CoV-2 in an indoor space. As a base case study, we built a model that simulated a poorly ventilated indoor 1000 square foot restaurant and the range of Covid-19 prevalence of actively infectious cases (best-case: 0.1%, base-case: 2%, and worst-case: 3%) and vaccination rates (best-case: 90%, base-case: 70%, and worst-case: 0%) in New York City. We evaluated the cost-effectiveness of improving ventilation rate to 12 air changes per hour (ACH), the equivalent of hospital-grade filtration systems used in emergency departments. We also provide a customizable online tool that allows the user to change model parameters. RESULTS: All 3 scenarios resulted in a net cost-savings and infections averted. For the base-case scenario, improving ventilation to 12 ACH was associated with 54 [95% Credible Interval (CrI): 29-86] aerosol infections averted over 1 year, producing an estimated cost savings of $152,701 (95% CrI: $80,663, $249,501) and 1.35 (95% CrI: 0.72, 2.24) quality-adjusted life years (QALYs) gained. CONCLUSIONS: It is cost-effective to improve indoor ventilation in small businesses in older buildings that lack HVAC systems during the pandemic.

Prediction of treatment nonadherence among older adults with chronic obstructive pulmonary disease using Medicare real-world data.

BACKGROUND: Suboptimal maintenance medication (MM) adherence remains a clinical problem among Medicare beneficiaries with chronic obstructive pulmonary disease (COPD). OBJECTIVE: To inform risk-based personalized decision-making, this study sought to develop and validate prediction models of nonadherence to COPD MMs for Medicare beneficiaries. METHODS: This was a retrospective cohort study of beneficiaries aged 65 years and older with COPD and inhaled MMs. Nonadherence (proportion of days covered < 0.8) was measured in 12 months following the first MM fill after COPD diagnosis. Logistic and least absolute shrinkage selector operator regressions were implemented, and area under the receiver operating characteristic curve (AUROC) evaluated model accuracy, as well as positive predictive values and negative predictive values. Our models evaluated different sets of predictors for two cohorts: those with an MM prescription before COPD diagnosis (prevalent users) and those without (new users). RESULTS: Among 16,157 prevalent and 40,279 new users of MMs, 11,271 (69.8%) and 34,009 (84.4%), respectively, were nonadherent. The best-performing logistic models achieved AUROCs of 0.8714 and 0.881, positive predictive values of 0.881 and 0.881, and negative predictive values of 0.559 and 0.578, respectively, for prevalent and new users. The least absolute shrinkage selector operator models had similar accuracy. Models with baseline-only predictors had average performance (AUROC < 0.72). The most important predictors were initial MM adherence, short-acting bronchodilator use, and asthma. CONCLUSIONS: To our knowledge, this study is the first to develop predictive models of nonadherence to COPD MMs. Generated models achieved good discrimination and underlined the importance of early adherence. Well-performed models can be useful for care decision-making and interventions to improve COPD medication adherence after the first critical few months following a treatment episode. DISCLOSURES: All authors declared no conflicts of interest.

External validation of lung function predictions in real-world cohorts of COPD.

BACKGROUND: An individualized FEV1 prediction model has recently been developed based on the Lung Health Study (LHS). An ongoing evaluation of the utility of prediction models in representative settings outside the setup of clinical trials is needed. OBJECTIVE: To evaluate the external validity of the LHS FEV1 prediction model in a representative sample of Canadian ever-smoker COPD patients. METHODS: We used the sample of ever-smokers with spirometrically-confirmed COPD from the Canadian Cohort of Obstructive Lung Disease (CanCOLD), an ongoing prospective, longitudinal, multicenter population-based cohort study. We compared the mean predicted against the mean observed FEV1 at follow-up visits. We calculated the root mean square error (RMSE) and the actual coverage probability of the 95% individualized prediction intervals. RESULTS: The final CanCOLD sample consisted of 360 ever-smoker COPD patients, contributing to 970 FEV1 observations over an average of 3 years of follow-up (standard deviation (SD): 0.6 years). The mean observed vs. predicted FEV1 for the first follow-up visit (1.67 years from baseline) was 2.28L vs. 2.28L, and for the second visit (3.13 years from baseline) was 2.19L vs. 2.18L. The RMSE of the predictions was 0.205L, and the actual coverage probability of the 95% prediction intervals was 93%. The model had a similar performance across multiple subgroups. CONCLUSIONS: The model showed robust performance in predicting FEV1 in the entire sample and in several subgroups of CanCOLD. Our results demonstrate that LHS predictions are valid for at least three years in the general COPD population.

Treat Now or Treat Later: Comparative Effectiveness of Adjuvant Therapy in Resected Stage IIIA Melanoma.

BACKGROUND: Adjuvant therapy for most sentinel-node-positive (stage IIIA) melanoma may have limited clinical benefit for older patients given the competing risk of non-cancer death. The objective of this study is to model the clinical effect and cost of adjuvant therapy in stage IIIA melanoma across age groups. STUDY DESIGN: A Markov decision analysis model simulated the overall survival of patients with resected stage IIIA melanoma treated with adjuvant therapy vs observation. In the adjuvant approach, patients are modeled to receive adjuvant pembrolizumab (BRAF wild type) or dabrafenib/trametinib (BRAF mutant). In the observation approach, treatment is deferred until recurrence. Transition variables were derived from landmark randomized trials in adjuvant and salvage therapy. The model was analyzed for age groups spanning 40 to 89 years. The primary outcome was the number needed to treat (NNT) to prevent one melanoma-related death at 10 years. Cost per mortality avoided was estimated using Medicare reimbursement rates. RESULTS: Projections for NNT among BRAF wild type patients increased by age from 14.71 (age 40 to 44) to 142.86 (age 85 to 89), with patients in cohorts over the age of 75 having an NNT over 25. The cost per mortality avoided ranged from $2.75 million (M) (age 40 to 44) to $27.57M (age 85 to 89). Corresponding values for BRAF mutant patients were as follows: NNT 18.18 to 333.33; cost per mortality avoided ranged from $2.75M to $54.70M. CONCLUSION: Universal adjuvant therapy for stage IIIA melanoma is costly and provides limited clinical benefit in patients older than 75 years.

A personalized biomedical risk assessment infographic for people who smoke with COPD: a qualitative study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) causes 3 million deaths each year, yet 38% of COPD patients continue to smoke. Despite proof of effectiveness and universal guideline recommendations, smoking cessation interventions are underused in practice. We sought to develop an infographic featuring personalized biomedical risk assessment through future lung function decline prediction (with vs without ongoing smoking) to both prompt and enhance clinician delivery of smoking cessation advice and pharmacotherapy, and augment patient motivation to quit. METHODS: We recruited patients with COPD and pulmonologists from a quaternary care center in Toronto, Canada. Infographic prototype content and design was based on best evidence. After face validation, the prototype was optimized through rapid-cycle design. Each cycle consisted of: (1) infographic testing in a moderated focus group and a clinician interview (recorded/transcribed) (with questionnaire completion); (2) review of transcripts for emergent/critical findings; and (3) infographic modifications to address findings (until no new critical findings emerged). We performed iterative transcript analysis after each cycle and a summative qualitative transcript analysis with quantitative (descriptive) questionnaire analysis. RESULTS: Stopping criteria were met after 4 cycles, involving 20 patients (58% male) and 4 pulmonologists (50% male). The following qualitative themes emerged: Tool content (infographic content preferences); Tool Design (infographic design preferences); Advantages of Infographic Messaging (benefits of an infographic over other approaches); Impact of Tool on Determinants of Smoking Cessation Advice Delivery (impact on barriers and enablers to delivery of smoking cessation advice in practice); and Barriers and Enablers to Quitting (impact on barriers and enablers to quitting). Patient Likert scale ratings of infographic content and format/usability were highly positive, with improvements in scores for 20/21 questions through the design process. Providers scored the infographic at 77.8% ("superior") on the Suitability Assessment of Materials questionnaire. CONCLUSIONS: We developed a user preference-based personalized biomedical risk assessment infographic to drive smoking cessation in patients with COPD. Our findings suggest that this tool could impact behavioural determinants of provider smoking-cessation advice delivery, while increasing patient quit motivation. Impacts of the tool on provider care, patient motivation to quit, and smoking cessation success should now be evaluated in real-world settings.

Evaluation of screening strategies for pulmonary tuberculosis among hospitalized patients in a low-burden setting: cost-effectiveness of GeneXpert MTB/RIF compared to smear microscopy.

OBJECTIVE: Hospitalized patients undergoing evaluation for pulmonary tuberculosis (TB) require airborne isolation while testing for Mycobacterium tuberculosis (MTB) to reduce risk of nosocomial transmission. GeneXpert MTB/RIF (Xpert) is more rapid and accurate than sputum smear microscopy, but it is not routinely used to 'rule out' infectious pulmonary TB among hospitalized patients in the United States. We sought to evaluate the diagnostic performance and cost-effectiveness of Xpert-based TB evaluation. METHODS: We conducted a retrospective cohort study of hospitalized adults evaluated for pulmonary TB at a large academic medical center in New York from 2010 to 2017. Using propensity score matching, we compared hospital length-of-stay among patients undergoing conventional smear-based TB evaluation to a control group with non-TB pneumonia. We performed a probabilistic cost-effectiveness analysis to compare Xpert-based versus conventional TB evaluation. RESULTS: In total 1,421 patients were evaluated for TB with airborne isolation and sputum testing; mycobacterial culture was positive for MTB in 49 (3.4%). Conventional TB evaluation was associated with an increase of 4.4 hospital days compared to propensity-matched controls. Xpert-based testing strategies dominated conventional TB evaluation with a cost savings of $5,947 (95% CI, $1,156-$12,540) and $4,445 (95% CI, $696-$9,526) per patient depending on the number of Xpert tests performed (1 vs 2, respectively) and assumptions about the reduction of length of stay achieved. CONCLUSIONS: In the evaluation of hospitalized patients for pulmonary TB, Xpert-based testing has superior diagnostic performance and is likely cost-effective compared to smear microscopy due to reduced hospital length-of-stay associated with more rapid test results.

Economic burden of comorbidities among COPD Patients hospitalized for acute exacerbations: an analysis of a commercially insured population.

INTRODUCTION: This study quantifies costs associated with comorbid conditions among adults diagnosed with chronic obstructive pulmonary disease (COPD) who experience acute exacerbations (AECOPD) needing inpatient hospitalization. METHODS: This retrospective cohort study used 2006-2015 IQVIA PharMetrics® Plus data, a health plan claims database. Patients aged 40-64 years, with AECOPD, defined as an inpatient hospitalization for a COPD-related diagnosis were included. The impact of comorbidities on AECOPD costs (costs of the COPD-related inpatient stay plus healthcare services used 30 days post-discharge) was determined using multivariable regression. The models adjusted for clinical complications, previous utilization, age, sex, region, year, length of hospitalization, and season of admission. RESULTS: Among these COPD patients, 89.5% had at least 1 comorbidity. The mean cost for AECOPD was 2015 US $19,687 (SD: 27,035, median: 11,539). Congestive heart failure, lipid disorders, cancer, and presence of any of the 10 most frequent comorbidities were associated with $1,921 (95% confidence interval (CI): 977-2,866), $1,619 (95% CI: 967-2,272), $8,347 (95% CI: 7,236-9,458), and $4,433 (95% CI: 3,598-5,268) higher costs, respectively than corresponding individuals without these comorbid conditions. Patients with depressive disorders were associated with $1,592 (95% CI: 828-2,355) lower costs compared to those without depressive disorders. CONCLUSION: COPD comorbidity imposes a significant economic burden on AECOPD.

Trends in Medicaid spending on inhalers in the United States, 2012-2018.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and asthma are common respiratory diseases that impose a significant economic burden on Medicaid. Inhalers are the mainstay treatment for relieving symptoms and improving outcomes for COPD and asthma patients. OBJECTIVE: To describe the total spending and trends of Medicaid expenditures on inhalers between 2012 and 2018 in the United States. METHODS: We analyzed the deidentified data from the Medicaid Drug Spending Dashboard and utilization datasets from 2012 to 2018. We identified 9 classes of inhalers and described the Medicaid total spending on and relative annual changes for those inhalers. We also described the spending on available generic inhalers and compared the Medicaid spending by manufacturers during this time frame. RESULTS: Medicaid spent $26.2 billion on inhalers from 2012 to 2018. This spending increased by $2.5 billion (120%) over this time frame. During this specified period, the highest Medicaid spending was on the group of inhaled corticosteroid (ICS)-containing inhalers ($14.9 billion). Within this group, the inhaler class of ICS/long-acting beta-2 adrenoceptor agonists contributed to the highest Medicaid spending (53%), with a growth of 607% between 2012 and 2018. Of the $26.2 billion that Medicaid spent on inhalers, $35.5 million (less than 0.01%) was spent on 2 generic inhalers: fluticasone propionate with salmeterol and levalbuterol tartrate hydrofluoroalkane. CONCLUSIONS: Between 2012 and 2018, on average, $3.5 billion per year was spent by Medicaid on inhalers. Decreasing the price of inhalers by introducing more generic inhalers in the market can potentially reduce the cost burden on Medicaid. DISCLOSURES: This study was funded by the American Foundation for Pharmaceutical Education (AFPE). The funders had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript. The authors declare no conflicts of interest.

The cost-effectiveness of common strategies for the prevention of transmission of SARS-CoV-2 in universities.

BACKGROUND: Most universities that re-open in the United States (US) for in-person instruction have implemented the Centers for Disease Prevention and Control (CDC) guidelines. The value of additional interventions to prevent the transmission of SARS-CoV-2 is unclear. We calculated the cost-effectiveness and cases averted of each intervention in combination with implementing the CDC guidelines. METHODS: We built a decision-analytic model to examine the cost-effectiveness of interventions to re-open universities. The interventions included implementing the CDC guidelines alone and in combination with 1) a symptom-checking mobile application, 2) university-provided standardized, high filtration masks, 3) thermal cameras for temperature screening, 4) one-time entry ('gateway') polymerase chain reaction (PCR) testing, and 5) weekly PCR testing. We also modeled a package of interventions ('package intervention') that combines the CDC guidelines with using the symptom-checking mobile application, standardized masks, gateway PCR testing, and weekly PCR testing. The direct and indirect costs were calculated in 2020 US dollars. We also provided an online interface that allows the user to change model parameters. RESULTS: All interventions averted cases of COVID-19. When the prevalence of actively infectious cases reached 0.1%, providing standardized, high filtration masks saved money and improved health relative to implementing the CDC guidelines alone and in combination with using the symptom-checking mobile application, thermal cameras, and gateway testing. Compared with standardized masks, weekly PCR testing cost $9.27 million (95% Credible Interval [CrI]: cost-saving-$77.36 million)/QALY gained. Compared with weekly PCR testing, the 'package' intervention cost $137,877 (95% CrI: $3,108-$19.11 million)/QALY gained. At both a prevalence of 1% and 2%, the 'package' intervention saved money and improved health compared to all the other interventions. CONCLUSIONS: All interventions were effective at averting infection from COVID-19. However, when the prevalence of actively infectious cases in the community was low, only standardized, high filtration masks clearly provided value.